ZIKAVAX PARTNERSHIP. Dr Odile LEROY DCVMN Seoul 26 th September 2017

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1 ZIKAVAX PARTNERSHIP Dr Odile LEROY DCVMN Seoul 26 th September

2 Product Development Partnership THE EUROPEAN VACCINE INITIATIVE IS A PRODUC T DEVELOPMENT PARTNERSHIP WHICH AIMS TO ACCELERATE THE DEVELOPMENT OF VACCINES FOR DISEASES OF POVERTY

3 First European PDP BY YEAR STARTED TDR Selected other public-private partnerships important for PDPs Adapted from IAVI 2013

4 4 About EVI To contribute to the global efforts to control diseases of poverty by supporting development and clinical assessment of vaccines for diseases of poverty Support translational vaccine R&D with focus on preclinical to early clinical development Operational, managerial and financial support Support capacity strengthening in low-income target regions Bringing together and aligning stakeholders

5 Initiatives Address the Entire Pipeline Antigen Discovery Validation cgmp Manufacture Formulation, Fill & Finish Toxicology,Stability,Potency Industrial Scale-up Licensure & Launch Phase 1a/b Safety Immunogenicity Phase II Immunogenicity Phase III Efficacy

6 Support in Vaccine Development Antigen Discovery Validation cgmp Manufacture Formulation, Fill & Finish Toxicology,Stability,Potency Industrial Scale-up Technical support & overview of process development, analytical procedures, GMP production, quality control, potency/nonclinical safety/stability studies etc Selection of sub-contractors Technical support and overview for adjuvant selection and testing Development and review of the Investigational Medicinal Product Dossier (IMPD) 6

7 Support in Vaccine Development Phase 1a/b Safety Immunogenicity Phase IIa Human Challenge Phase IIb Immunogenicity Efficacy Selection of sponsor and investigational site Development and review of the clinical development plan, clinical trial protocol, methodology etc Technical support for clinical trial application/review to ethic committee and regulatory agency 7

8 How is EVI addressing the global need for new vaccines? Feed the pipeline FIRST! - PDP Coordination connecting the chain Harmonisation guidelines, procedures Building European infrastructure with global network TRANSVAC2 project 1 st call 15/10/2017 8

9 Public-Private Partnership for Product Development Heidelberg University Germany Headquarter The Jenner Vaccine Foundation United Kingdom Stockholm University Sweden Biomedical Primate Research Centre The Netherlands Royal College of Surgeons in Ireland Ireland Institute for Translational Vaccinology, Bilthoven The Netherlands Institut Pasteur, Paris France CONFIDENTIAL 9

10 Partnership Principles and Strategy for Success To involve affected population and their policy makers in strategy for development plan et setting priorities (diseases, products): objectives developed together product development (including analysis of the results (both safety and efficacy) AND capacity building infrastructure and training) Need to call funding agencies to have a global portfolio management (as for malaria, tb and hiv vaccine) for PRND assessing gaps and defining priorities To call funding agencies to have a global portfolio management assessing gaps and defining priorities global portfolio management AND connecting the chain CONFIDENTIAL 10

11 Partnership Principles and Strategy for Success To have sustainable pipeline populated with enough candidate to increase chance of success To advocate for pooled funding mechanisms with FRESH funding to manage global portfolios. Funders should explicitly include product development aspect into their funding mechanism, as well as the requirement for the applicants to outline their access policies. CONFIDENTIAL 11

12 ZIKAVAX Fast track development of a Zika vaccine based on measles vector Duration: 48 months Total grant: 4,918, EC-funded project under H

13 Objectives 1. To construct and characterise recombinant MV expressing Zika virus proteins as soluble secreted antigens 2. To demonstrate preclinical immunogenicity and protective efficacy of the recombinant MV-Zika vaccine candidate(s) in a mouse model and in a non-human primate (NHP) model of Zika virus infection 3. To manufacture a good manufacturing practice (GMP) clinical lot of the MV-Zika vaccine candidate using scalable platform technology 4. To assess the safety and immunogenicity of the MV-Zika vaccine candidate in a phase I dose-escalation clinical trial

14 ZIKAVAX Methodology Delivery platform technology: measles vaccine vector (live attenuated) demonstrated proof of principle in clinical and pre-clinical studies. Rapid adaptability and effectiveness for a variety of pathogens (Chikungunya virus, West Nile virus, Ebola, Plasmodium, Mycobacterium) Optimised manufacturing process high yields and purity using standards equipment Rapid transfer to other manufacturers for any outbreak Ultimate objective is the demonstration of safety and immunogenicity in adults in a Phase 1 clinical trial 14

15 Technology platform: Measles Vector Inventor: Dr Frederic Tangy Institut Pasteur (France) Development: Themis Bio (Austria) MV genes are indicated: N (nucleoprotein), PVC (phoshoprotein and V/C proteins), M (matrix), F (fusion), H (hemagluttinin), L (polymerase), T7 (T7 RNA polymerase promoter), hh (hammerhead ribozyme), T7t (T7 RNA polymerase terminator), (hepatitis delta virus ribozyme), red arrows (additional transcription units).

16 Global Portfolio 16

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18 Vaccine Pipeline : ~ 50 projects from 27 institutions/organisations Antigen Discovery Validation cgmp Manufacture Formulation, Fill & Finish Toxicology,Stability,Potency Industrial Scale-up Phase 1a/b Safety Immunogenicity Phase IIa Human Challenge Phase IIb Immunogenicity Efficacy 5 inactivated whole virus vaccines 5 live attenuated whole virus vaccines 11 recombinant sub-unit non VLP/VLP 11 recombinant viral vector vaccine 4 DNA or RNA or peptide ~ 10 vaccine in phase I/II clinical trial 18

19 More to come 19

20 Issues and concerns for vaccine development Animal models 20

21 Issues and concerns for vaccine development Animal models 21

22 And more Further development needed for vaccine development 1. Human challenge models VALIDATION & FEASIBILITY 1. Definition and validation of correlates/surrogates of protection HARMONISATION & STANDARDISATION OF IMMUNO-ASSAYS Further investigations needed for vaccine development 1. Cross reactivity with other flavivirus 2. Epidemiology pattern 22

23 Acknowledgements EVI donors DGIS (NL) Irish Aid (IE) BMBF via KfW (DE) BMBF (DE) FP6/FP7 (EC) EDCTP (EC & EU MS) IMI-IMI2 GHIT Nobelpharma Subjects in EVI funded clinical trials EVI sub-contractors, CMOs, CROs, Consultants Scientific Community Europe, Africa, India, Japan, USA EVI EEIG members Stockholm University, SE Heidelberg University, DE Royal College of Surgeon in Ireland, IE Jenner Vaccine Foundation-University of Oxford, UK Biomedical Primate Research Centre, NL Intravacc, NL Institut Pasteur, FR Many thanks for your attention! -

24 You can Contribute to make a better world free of diseases of poverty